Advantix Spot-on solution for dogs over 10 kg up to 25 kg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imidacloprid; Permethrin (Cis:Trans 40:60)

Available from:

Elanco GmbH

ATC code:

QP53AC54

INN (International Name):

Imidacloprid; Permethrin (Cis:Trans 40:60)

Dosage:

250.0/1250.0 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

permethrin, combinations

Authorization status:

Authorised

Authorization date:

2004-04-02

Summary of Product characteristics

Health Products Regulatory Authority
19 March 2021
CRN009KPT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Advantix Spot-on solution for dogs over 10 kg up to 25 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 2.5 ml contains:
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ACTIVE SUBSTANCES:
Imidacloprid
250.0
mg
Permethrin: (40/60)
1250.0 mg
EXCIPIENT(S):
Butylhydroxytoluene (E321):
2.5
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear yellowish to brownish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (over 10 kg up to 25 kg).
For dogs less than or equal to 10 kg or more than 25 kg body weight,
use the appropriate Advantix Spot-on solution product
(see section 4.9).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of flea (_Ctenocephalides canis_,
_Ctenocephalides felis_) infestation.
Fleas on dogs are killed within one day following treatment. One
treatment prevents further flea infestation for four weeks. The
product can be used as part of a treatment strategy for flea allergy
dermatitis (FAD).
For the treatment of biting lice (_Trichodectes canis_).
The product has persistent acaricidal and repellent efficacy against
tick infestations (_Rhipicephalus sanguineus _and _Ixodes _
_ricinus _for four weeks, and _Dermacentor reticulatus _for three
weeks)_._
By repelling and killing the tick vector _Rhipicephalus sanguineus,
_the product reduces the likelihood of transmission of the
pathogen _Ehrlichia canis, _thereby reducing the risk of canine
ehrlichiosis. The reduction in risk has been shown in studies to
commence from 3 days following application of the product and to
persist for 4 weeks.
Ticks already on the dog may not be killed within two days after
treatment and may remain attached and visible. Therefore the
removal of ticks already on the dog at the time of treatment is
recommended, in order to prevent them from attaching and
having a blood meal.
One treatment provides repellent (anti-f